Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA has approved Idorsia’s new drug Tryvio, a New Molecular Entity (NME) drug Aprocitentan for
FDA has approved Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) for treatment of fatty liver disease (Noncirrhotic Nonalcoholic
Indian Pharma company Orchid Pharma’s New Molecular Entity (NME) Enmetazobactam gets USFDA approval for treatment
FDA has approved Novartis’ Iptacopan (Fabhalta) for treatment of rare blood disease, Paroxysmal Nocturnal Hemoglobinuria
Desmoid tumors are non-cancerous, but locally aggressive and invasive soft-tissue tumors that can lead to
AstraZeneca’s TRUQAP (New Molecule Capivasertib) in combination with Faslodex (Fulvestrant) has been approved in the
Danish Pharma firm Ascendis Pharma announced the European Commission approval for palopegteriparatide (Yorvipath), for treatment
FDA approves Evive Biotech’s Ryzneuta for the management of chemotherapy-induced neutropenia (incidence of infection, as
Bristol Myers Squibb Augtyro™ (repotrectinib) is approved for treatment of adult patients with ROS1-positive non-small
Vamorolone is a synthetic corticosteroid approved by USFDA for the treatment of Duchenne Muscular Dystrophy
